* Lead the Regulatory Affairs Team with direct reports and external reporting from regulatory consultants.
* Lead MDR:2017/745 compliance project to achieve CE certification for all medical devices
* Lead projects in cooperation with external consultants and internal teams for the registration of our Medical devices predominantly within European Economic Area and later to other global markets.
* Work together with CROs to review and approve Clinical Evaluation reports and PMCF plans.
* Responsible for evaluation and submission of applications for new product and application approvals to our notified body.
* Documentation and evaluation of device technical documentation to comply national & regional regulations.
* Support QM and Risk team in ensuring compliance with EN ISO 13485:2016 and EN ISO 14971 requirements.
* Stakeholder for Change Control meeting for evaluation of product design and process changes.
* Point of contact for consultation on regulatory questions from all cross functional teams.
* Responsible for the creation and maintenance of technical documentation over the entire product life cycle.
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Regulatory Manager
- Location Berlin
- Job type Permanent
- Salary 30 days holiday
- Discipline Regulatory
- Reference PR/258262_1584365863